Alerting systems have been used as part of safety practices in various industries. For example, in the 1930s, submarines were introduced with a novel alerting system. Historically, accidents occurred when major openings through the pressure hull had not been closed prior to diving. These apparently obvious errors had resulted in the loss of boats and lives. To improve communication about the status of the submarine, an alerting system was developed. This system incorporated visual feedback to the dive officer and the captain about the status of all openings to the sea. When a particular hull opening was not closed to the sea, the corresponding indicator would be set to a “Red” colored state. When this hull opening was closed, the indicator would be set to a “Green” state. The submarine personnel could quickly glance at the state of the “Greenboard” or “Christmas Tree” prior to giving the order to dive. This safety system is believed to have reduced the likelihood of loss of submarines in the United States Navy.
In aviation, similar safety systems have been implemented. Some of the more advanced aviation systems have incorporated electronic checklists with visual and auditory alerting. Other industries in which operational safety is paramount, including the nuclear power industry and in the launching of nuclear missiles, have incorporated similar alerting systems.
The Agency for Health Care Research and Quality (AHRQ) has proposed that medical institutions introduce safety practices similar to those used in other industries. An analysis of “sentinel events,” events involving death or serious injury, has found that the Operating Room (OR) has the highest incidence of patient safety “events.” Examples of OR events that represent potential opportunities for improvement include anything that does or could cause patient harm. Examples of events that do or could contribute to patient harm include: wrong site surgical procedures, not providing needed medications, incorrect timing of medications, incomplete instrumentation, incorrect instrumentation, lack of needed supplies, incorrect supplies, lack of medical records, lack of relevant imaging, sponge counting, needle counting, and others.
Additionally, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has begun to survey all JCAHO accredited health care organizations for implementation of the following recommendations—or acceptable alternatives—as appropriate to the services the organization provides. Failure by an organization to implement any of the applicable recommendations (or an acceptable alternative) will result in a special Type I recommendation. The specific goals of this initiative include:    1. Improve the process of patient, surgical site and procedure verification.            a. Extend the current preoperative verification process by implementing an electronic checklist.        b. Facilitate this identification and comply with 2003 JCAHO criteria by confirming and recording that appropriate documents (e.g., medical records, imaging studies) are available at the time of the surgical episode.        c. Implement a process to mark the surgical site and involve the patient in the marking process.            2. Improve the effectiveness of communication among caregivers in the delivery of surgical care.    3. Improve the timely administration of prophylactic antibiotics.    4. Improve the effectiveness of clinical alerting systems.    5. Provide a closed loop feedback system to support ongoing process improvement.
Presently, most procedures that are implemented to reduce “sentinel events” comprise manual checklists. Not only is the use of such lists cumbersome, manual checklists are prone to error by the person completing the checklist. Also, if a step is omitted, it is often difficult to determine if the step had actually been omitted, or if the person performing the step merely failed to fill out the form. This is particularly problematic if the oversight is not noted immediately. The automated checklist in U.S. Pat. No. 5,267,147 overcomes some of these shortcomings, but relies on sequential review of checklist items.
Medical alert or alarm systems for equipment operation or patient conditions are also known. U.S. Pat. Nos. 5,319,355 and 5,534,851 provide an alarm for a life support system that provides information for “medical conditions of patients and the status and operational conditions of any medical equipment that may be used in a pre-hospital, post-hospital, or in-hospital setting.” Col. 3, lines 29–32 (See also Col. 4, lines 7–22). U.S. Pat. No. 5,416,695 discloses a medical alert system used for medical and geodetic information, such as for use with ambulatory patients. U.S. Pat. No. 5,579,775 teaches a telemetry system for monitoring a patient's physiological conditions. U.S. Pat. No. 6,032,035, discloses a portable transmitter for an emergency response system, and U.S. Pat. No. 6,607,481, discloses an emergency call system for dispatchers. U.S. Publication Nos. 2002/0082480 and 2002/0120310, disclose systems for management of medical devices. U.S. Publication 2003/0022815 displays tasks for patient care, and PCT Publication No. WO 94/22098 discloses a patient care and communication system. While many of these alert systems and automated checklists, the references for which are herein incorporated by reference, could be used in connection with the present invention, none of these systems teaches a display of the status of various safety activities applicable to a particular healthcare environment.
It is desired to provide an alert system for patient care, illustratively for use in various healthcare environments, such as the operating room, that easily alerts appropriate medical personnel of any deficiencies, including missing information, tests, or materials required for surgery. Such a system would operate to minimize events that do or could cause harm to the patient. Illustratively, the system would provide appropriate alerts in pre-operative, operative, and post-operative environments. However, it is understood that the systems and methods may be used for other aspects of patient care.